Rheumatoid arthritis (RA) The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Humira.
Conditions
Sponsors
Karolinska Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: RA patients: Age =18 , Fulfilling ACR criteria for RA, Disease duration = 10 years. The responsible Rheumatologist has found need for antirheumatic treatment with Humira. Patients should not have have had treatment with adalimumab before. However, use of maximum one previous TNF-blocker (infliximab, etanercept, golimumab or certolizumab) and/or one other biologic treatment (abatacept, rituximab or tocilizumab) is allowed (=40 patients in the whole study).TNF-blockers should have been withdrawn > 2 months before study entry. The latest administration of abatacept or tocilizumab should have been given > 2 months prior to study entry. The latest administration of rituximab should have been given > 3 months prior to study entry. Healthy controls: Healthy volunteers, age =18. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: RA patients: Fulfilling ACR criteria for fibromyalgia. For fMRI – left handedness and all forms of metallic implants. Severe ischemic heart disease. Concurrent treatment with antidepressant drugs. Contraindication to adalimumab. Healthy controls (group C): Fulfilling ACR criteria for fibromyalgia. For fMRI – left handedness and all forms of metallic implants. Severe ischemic heart disease. Concurrent treatment with antidepressant drugs. Concurrent neurological disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and how these mechanisms are influenced by TNF-blockade with Humira;Secondary Objective: To investigate effects of Humira on peripheral pain, fatigue and autonomic function in RA;Primary end point(s): Not applicable as this is not a trial of a new drug and the goal is to investigate mechanisms of pain processing before and after Humira treatment. The reason for using placebo-control in the study is to minimize inter-individual differences that can greatly affect the fMRI results and make conclusions diffucult Brief description of the protocol: RA patients with insufficient disease control on methotrexate will be randomized into two groups: One will recieve Humira at baseline, after 2 and 4 weeks as usual whereas the other group will recieve placebo injections at baseline, after 2 and 4 weeeks. At baseline (pat and controls) and after 4 weeks (patients only) of treatment/placebo patients and healthy controls will undergo clinical evaluation with assessment of DAS28 and other disease parameters, blood sampling, fMRI with pain stimuli in a predefined scheme, pain assessments, algometry for measurement of peripheral pain, assessment of heat pain thresholds and heart rate variability for measurement of autonomic activity. After 4 weeks, all patients will recieve Humira and there will be a clinical evaluation, and pain assessments (but not fMRI) at 12 weeks. This is the endpoint. Clinical response and pain effects of Humira will be evaluated but this is not the primary goal with the study. | — |
Countries
Sweden
Outcome results
None listed